Methods and apparatus for off-axis visualization

ABSTRACT

Methods and apparatus for off-axis visualization are described herein. An endoluminal tissue manipulation assembly is disclosed which provides for a stable endoluminal platform and which also provides for effective triangulation of tools. Such an apparatus may comprise an optionally shape-lockable elongate body defining a longitudinal axis and adapted for endoluminal advancement in a patient body, at least one articulatable visualization lumen disposed near or at a distal region of the elongate body, the at least one articulating visualization lumen being adapted to articulate off-axis relative to a longitudinal axis of the elongate body, and at least one articulatable tool arm member disposed near or at the distal region of the elongate body, the at least one articulatable tool arm member being adapted to articulate off-axis and manipulate a tissue region of interest.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.11/365,088, filed Feb. 28, 2006, and now pending, which is acontinuation-in-part of U.S. patent application Ser. No. 11/129,513filed May 13, 2005 and now abandoned. U.S. patent application Ser. No.11/129,513 is a continuation-in-part of U.S. patent application Ser. No.10/824,936 filed Apr. 14, 2004, now pending, and also claims priority toU.S. Provisional Patent Application No. 60/670,426 filed Apr. 11, 2005.Each of these applications is incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to methods and apparatus for performingendoluminal procedures within a body lumen. More particularly, thepresent invention relates to methods and apparatus for visualizingand/or performing procedures endoluminally within a body lumen utilizingoff-axis articulation and/or visualization.

Medical endoscopy entails the insertion of an elongate body into a bodylumen, conduit, organ, orifice, passageway, etc. The elongate bodytypically has a longitudinal or working axis and a distal region, and avisualization element disposed near the distal region in-line with theworking axis. The visualization element may comprise an optical fiberthat extends through the elongate body, or a video chip having animaging sensor, the video chip coupled to or including asignal-processing unit that converts signals obtained by the imagingsensor into an image. The elongate body may also include a working lumento facilitate passage of diagnostic or therapeutic tools therethrough,or for injection of fluids or to draw suction.

The maximum delivery profile for a medical endoscope may be limited bythe cross-sectional profile of the body lumen, conduit, organ, orifice,passageway, etc., in which the endoscope is disposed. At the same time,advances in therapeutic endoscopy have led to an increase in thecomplexity of operations attempted with endoscopes, as well as thecomplexity of tools advanced through the working lumens of endoscopes.As tool complexity has increased, a need has arisen in the art forendoscopes having relatively small delivery profiles that allow accessthrough small body lumens, but that have relatively large working lumensthat enable passage of complex diagnostic or therapeutic tools.Furthermore, as the complexity of operations attempted with endoscopeshas increased, there has arisen a need for enhanced visualizationplatforms, including three-dimensional or stereoscopic visualizationplatforms.

As with endoscopy, ever more challenging procedures are being conductedutilizing laparoscopic techniques. Due to, among other factors, theprofile of instruments necessary to perform these procedures, as well asa need to provide both visualization and therapeutic instruments,laparoscopic procedures commonly require multiple ports to obtain thenecessary access. Multiple ports also may be required due to the limitedsurgical space accessible with current, substantially rigidstraight-line laparoscopic instruments.

Moreover, conventional endoscopes and instruments provide generallyinadequate platforms to perform complex surgeries within patient bodies.The flexible nature of conventional endoscopes and the structuralweakness and functional limitations of the instruments passed throughsmall channels within the endoscopes make vigorous tissue manipulationand organ retraction extremely difficult.

Instruments pushed distally through a retroflexed gastroscope, forexample, simply push the unsupported endoscope away from the targettissue. As the instrument is further advanced against the tissuesurface, the endoscope is typically flexed or pushed away from thetissue region due to a lack of structural rigidity or stability inherentin conventional endoscopes.

Endoscopic surgery is further limited by the lack of effectivetriangulation due in part to a 2-dimensional visual field typicallyprovided by an endoscope which limits depth perception within the bodylumen. Moreover, conventional endoscopic procedures are generallylimited to instruments which allow only for co-axial force exertionalong a longitudinal axis of the endoscope and instruments which have aninability to work outside of the endoscopic axis.

In view of the foregoing, it would be desirable to provide methods andapparatus for performing endoluminal procedures that facilitateintroduction of the apparatus into relatively small body lumens, whileproviding for introduction of at least one relatively large tool, ascompared to standard endoscopes or laparoscopes. It also would bedesirable to provide methods and apparatus that facilitate single portlaparoscopy.

BRIEF SUMMARY OF THE INVENTION

The endoluminal tissue treatment assembly described herein may comprise,in part, a flexible and elongate body which may utilize a plurality oflocking links which enable the elongate body to transition between aflexible state and a rigidized or shape-locked configuration. Details ofsuch a shape-lockable body may be seen in further detail in U.S. Pat.Nos. 6,783,491; 6,790,173; and 6,837,847, each of which is incorporatedherein by reference in its entirety.

Additionally, the elongate body may also incorporate additional featuresthat may enable any number of therapeutic procedures to be performedendoluminally. An elongate body may be accordingly sized to beintroduced per-orally. However, the elongate body may also be configuredin any number of sizes, for instance, for advancement within and forprocedures in the lower gastrointestinal tract, such as the colon.

The assembly, in one variation, may have several separate controllablebending sections along its length to enable any number of configurationsfor the elongate body. For instance, in one variation, elongate body mayfurther comprise a bending section located distal of the elongate body;the bending section may be configured to bend in a controlled mannerwithin a first and/or second plane relative to the elongate body. In yetanother variation, the elongate body may further comprise anotherbending section located distal of the first bending section. In thisvariation, the bending section may be configured to articulate inmultiple planes, e.g., 4-way articulation, relative to the first bendingsection and elongate body. In a further variation, a third bendingsection may also be utilized along the length of the device.

In yet another variation, each of the bending sections and the elongatebody may be configured to lock or shape-lock its configuration into arigid set shape once the articulation has been desirably configured. Anexample of such an apparatus having multiple bending sections which maybe selectively rigidized between a flexible configuration and ashape-locked configuration may be seen in further detail in U.S. Pat.Pubs. 2004/0138525 A1; 2004/0138529 A1; 2004/0249367 A1; and2005/0065397 A1, each of which is incorporated herein by reference inits entirety.

As the bending sections may be articulated in any number ofconfigurations via control wires routed through the elongate body, theassembly may be actively steered to reach all areas of the stomach,including retroflexion to the gastroesophageal junction. The assemblymay also be configured to include any number of features such as lumensdefined through the elongate body for insufflation, suction, andirrigation similar to conventional endoscopes.

Once a desired position is achieved within a patient body, the elongatebody may be locked in place. After insertion and positioning, the distalend of a visualization lumen can be elevated above or off-axis relativeto the elongate body to provide off-axis visualization. The off-axisvisualization lumen may be configured in any number of variations, e.g.,via an articulatable platform or an articulatable body to configureitself from a low-profile delivery configuration to an off-axisdeployment configuration. The visualization lumen may define a hollowlumen for the advancement or placement of a conventional endoscopetherethrough which is appropriately sized to provide off-axisvisualization during a procedure.

Alternatively, various imaging modalities, such as CCD chips and LEDlighting may also be positioned within or upon the lumen. In yet anotheralternative, an imaging chip may be disposed or positioned upon or nearthe distal end of lumen to provide for wireless transmission of imagesduring advancement of the assembly into a patient and during aprocedure. The wireless imager may wirelessly transmit images to areceiving unit located externally to a patient for visualization.Various examples of various articulatable off-axis visualizationplatforms may be seen in further detail in U.S. patent application Ser.No. 10/824,936 filed Apr. 14, 2004, which is incorporated herein byreference in its entirety.

In addition to the off-axis visualization, an end effector assemblyhaving one or more articulatable tools, e.g., graspers, biopsy graspers,needle knives, snares, etc., may also be disposed or positioned upon ornear the distal end of the assembly. The tools may be disposedrespectively upon a first and a second articulatable lumen. Each of thearticulatable lumens may be individually or simultaneously articulatedwith respect to bending section and the off-axis lumen and any number oftools may be advanced through the assembly and their respective lumens.During advancement endoluminally within the patient body, tools may beretracted within their respective lumens so as to present an atraumaticdistal end to contacted tissue. Alternatively, tools may be affixed uponthe distal ends of lumens and atraumatic tips may be provided thereuponto prevent trauma to contacted tissue during endoluminal advancement.

Any number of lumens, articulatable or otherwise, may be utilized aspracticable. Examples of articulatable lumens are shown in furtherdetail in U.S. Pat. Pubs. 2004/0138525 A1; 2004/0138529 A1; 2004/0249367A1; and 2005/0065397 A1, each of which have been incorporated byreference above.

The utilization of off-axis visualization and off-axis tool articulationmay thereby enable the effective triangulation of various instruments topermit complex, two-handed tissue manipulations. The endoluminalassembly may accordingly be utilized to facilitate any number ofadvanced endoluminal procedures, e.g., extended mucosal resection,full-thickness resection of gastric and colonic lesions, and gastricremodeling, among other procedures. Moreover, the endoluminal assemblymay be utilized in procedures, e.g., trans-luminal interventions toperform organ resection, anastomosis, gastric bypass or other surgicalindications within the peritoneal cavity, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an illustrative view of one variation of an endoluminaltissue treatment assembly having a handle, an optionally rigidizableelongate body, and an end effector assembly with articulatable off-axistool arms and articulatable off-axis visualization.

FIGS. 2A and 2B show illustrative perspective views of a variation ofthe end effector assembly in a deployed configuration and a low-profiledelivery configuration, respectively.

FIG. 3 shows a side view of the end effector assembly of FIGS. 2A and2B.

FIGS. 4A and 4B illustrate a typical view of the articulatable off-axistool arms performing a procedure on a tissue region of interest from theperspective of the off-axis visualization lumen.

FIG. 5 illustrates another variation of the off-axis visualization lumenin one deployed configuration.

FIG. 6 shows another variation of the end effector assembly in which theoff-axis visualization assembly may be utilized with at least onearticulatable off-axis tool arm.

FIG. 7 shows another variation of the end effector assembly in which aninflatable balloon may be utilized for providing an atraumatic surfaceduring low-profile advancement of the end effector.

FIG. 8 shows another variation in which a cap may be utilized at thedistal end of the assembly to provide an atraumatic surface forlow-profile advancement.

FIG. 9 shows yet another variation of the off-axis visualization lumenin which an articulatable lumen disposed upon a reconfigurable platformmay be configured such that visualization of the tissue region ofinterest directly beneath the imager may be provided.

FIG. 10 shows yet another variation of the off-axis visualization lumenattached to the distal end of the elongate body.

FIG. 11 illustrates an exploded assembly view of one variation for thetool arms.

FIG. 12 illustrates a side view of the tool arms in a deployedconfiguration.

FIGS. 13A to 13D illustrate possible movements of the articulatableoff-axis tool arms relative to the elongate body.

FIG. 14 illustrates the possible longitudinal advancement of at leastone tool arm relative to the elongate body.

FIG. 15 illustrates the possible rotational motion of at least one toolarm about its longitudinal axis relative to the elongate body.

FIG. 16 illustrates some of the possible articulation of the tool armsrelative to one another.

FIGS. 17A and 17B illustrate one example for advancing an elongate bodytransesophageally into the stomach for performing a procedure.

FIGS. 18A to 18C illustrate another variation of the elongate bodyhaving two adjacent sections which are articulatable relative to eachother and which are also optionally rigidizable to retain a desiredconfiguration.

FIGS. 18D and 18E illustrate yet another variation of the elongate bodyhaving three adjacent sections which are all articulatable relative toeach other and which are also optionally rigidizable to retain a desiredconfiguration.

FIGS. 18F to 18H illustrate an example of a three-sectioned variation ofthe elongate body being advanced transesophageally into the stomach andarticulated to position its distal end near or adjacent to thegastroesophageal junction.

FIG. 18I illustrates another example of FIGS. 18F to 18H in which atleast one the bendable sections may be articulated in an opposingdirection relative to the remaining two bendable sections to furtherarticulate the elongate body within the stomach.

FIG. 19 shows an end view of one variation of the cross-section of theelongate body providing two lumens for their respective tool arms and asingle lumen for the visualization apparatus or endoscope.

FIGS. 20A and 20B show end and side views of an example of an individuallink through which the working lumens may be positioned.

FIGS. 21A and 21B show other variations of the cross-section of theelongate body providing two lumens for their respective tool arms, alumen for visualization, and an auxiliary lumen for an additionalinstrument to be passed therethrough.

FIG. 21C shows a perspective view of an example for lumen positioningrelative to one another for the configuration of FIG. 21A.

FIGS. 22A and 22B show perspective detail views of an example of thehandle assembly optionally having a rigidizable elongate body; in afirst configuration in FIG. 22A, rigidizing control is actuated ordepressed to rigidize or shapelock the elongate body and in a secondconfiguration in FIG. 22B where rigidizing control may be released toplace the elongate body in a flexible state.

FIG. 22C shows an end view of the handle of FIG. 22B revealing the openlumen for the passage of tools, instruments, and/or visualizationfibers, etc., therethrough.

FIG. 23 shows an exploded perspective view of a sealable or gasketedport assembly which may be attached to the handle for passing toolsand/or instruments therethrough while maintaining a seal.

FIGS. 24A and 24B illustrate perspective and partial cross-sectionalside views, respectively, of yet another variation of the endoluminaltissue treatment assembly having an endoscope which may be passedthrough an opening in the elongate body, which is optionallyrigidizable, for providing off-axis visualization.

FIGS. 25A and 25B illustrate yet another variation where thearticulatable sections of the elongate body may be configured to havedifferent lengths.

FIG. 26 shows another variation in which the articulatable tools may bepassed through an opening defined along the elongate body which also hasan articulatable distal portion to provide for off-axis visualization.

FIGS. 27A to 27C show yet another variation in which the tool arms maybe configured to have predetermined configurations once advanceddistally of the elongate body.

FIG. 27D shows yet another variation in which the articulatable toolarms may be freely rotated relative to the elongate body.

FIG. 28 shows yet another variation in which an imaging chip, e.g., aCCD chip, may be disposed upon the end of a guidewire having apredetermined configuration to provide for visualization of the tissueregion; the imaging chip may transmit its images via wire through theguidewire or wirelessly to a receiver located externally of a patientbody.

FIG. 29 shows yet another variation in which an imaging chip may bedisposed upon a pivoting member.

FIG. 30 shows another variation where imaging and/or lighting during aprocedure may be provided via imaging capsules and/or LEDs temporarilyattached within the patient body and which transmit their imageswirelessly to a receiver outside the patient body.

FIG. 31A shows an imaging assembly or endoscope passed through anopening or skive defined along the outer surface of an elongate body.

FIG. 31B shows a cross-sectional illustration of the articulatableimaging assembly having a rotatable housing contain an imager.

FIGS. 32A to 32C show an instrument utilizing a pull-wire to control theoff-axis articulation of the imaging assembly.

FIGS. 33A and 33B show an elongate body having a swing arm rotatablyconnected via a pivot to direct the positioning of the imaging assemblyin an off-axis configuration.

FIGS. 34A and 34B show a balloon assembly which may be configured toconform into a bent or curved configuration for positioning of theimaging assembly in an off-axis configuration.

FIGS. 35A and 35B show a sleeve having a pre-formed bend or curve shapewhich may be wrapped or at least partially surrounded around anendoscope to position the imaging assembly in an off-axis configuration.

FIGS. 36A and 36B show a sleeve made from an electro-active polymerwhich may be actuated to reconfigure a position of the imaging assembly.

FIGS. 37A and 37B show side and end views, respectively, of a variationutilizing two or more off-axis visualization elements which arereconfigurable between a straightened and curved configuration.

FIGS. 38A and 38B show another variation where two or more off-axisvisualization elements may be constrained within a retractable retainingsleeve.

FIGS. 39A and 39B illustrate an inflatable balloon assembly in anun-inflated and inflated state where the balloon defines one or morecurved lumens therethrough for passing tools or instruments through.

FIG. 39C shows a perspective view of the assembly of FIG. 39B with theballoon in its inflated configuration.

FIGS. 40A and 40B show an endoscope or imaging assembly which may bearticulated from a first off-axis position to a second off-axis positionto result in an expanded field-of-view.

FIGS. 41A and 41B show another variation for articulating an endoscopeor imaging assembly from a first off-axis position to a proximal secondoff-axis position through an opening or skive along the elongate body.

FIG. 42 shows an example of an elongate body which utilizes multipleskives along its length.

FIGS. 43A and 43B show side and partial cross-sectional side views,respectively, of an in-line imaging assembly for providing off-axisvisualization utilizing a rotatable element.

FIGS. 44A and 44B show partial cross-sectional side and end views,respectively, of another variation of an in-line imaging assemblyutilizing one or more pivoting reflectors.

FIG. 45A shows an example of a visualization enhancement where animaging assembly may provide multiple adjacent imaging chips, e.g., CCDor CMOS.

FIGS. 45B to 45E illustrate how sequential imaging, capturing, andprocessing of the captured images can be utilized to provide forpanoramic endoluminal visualization.

FIG. 46 illustrates another example for image enhancement utilizing acombined fluoroscopic-endoscopic imaging system for display on a monitorand/or goggles.

DETAILED DESCRIPTION OF THE INVENTION

Endoluminal access may be achieved more effectively by utilizingoff-axis articulation with an endoluminal tissue manipulation assemblyadvanced within a body lumen, e.g., advanced endoluminally orlaparoscopically within the body lumen. As described herein, off-axisarticulating elements may act as reconfigurable platforms from whichvarious tools and/or imagers may be advanced or therapies may beconducted. Once the assembly has been desirably situated within thebody, a versatile platform from which to access, manipulate, andvisualize a greater portion of the body lumen may be deployed from adevice having a relatively small delivery profile.

With reference to FIG. 1, the endoluminal tissue manipulation 10assembly as described herein may comprise, at least in part, a distalend effector assembly 12 disposed or positionable at a distal end of aflexible and elongate body 14. A handle assembly 16 may be connected toa proximal end of the elongate body 14 and include a number of featuresor controls for articulating and/or manipulating both the elongate body14 and/or the distal end effector assembly 12.

The elongate body 14 may optionally utilize a plurality of locking orlockable links nested in series along the length of the elongate body 14which enable the elongate body 14 to transition between a flexible stateand a rigidized or shape-locked configuration. Details of such ashape-lockable body may be seen in further detail in U.S. Pat. Nos.6,783,491; 6,790,173; and 6,837,847, each of which is incorporatedherein by reference in its entirety. Alternatively, elongate body 14 maycomprise a flexible body which is not rigidizable or shape-lockable butis flexible in the same manner as a conventional endoscopic body, if sodesired. Additionally, elongate body 14 may also incorporate additionalfeatures that enable any number of therapeutic procedures to beperformed endoluminally. Elongate body 14 may be accordingly sized to beintroduced per-orally. However, elongate body 14 may also be configuredin any number of sizes, for instance, for advancement within and forprocedures in the lower gastrointestinal tract, such as the colon.

Elongate body 14, in one variation, may comprise several controllablebending sections along its length to enable any number of configurationsfor the elongate body 14. Each of these bending sections may beconfigured to be controllable separately by a user or they may all beconfigured to be controlled simultaneously via a single controller.Moreover, each of the control sections may be disposed along the lengthof elongate body 14 in series or they may optionally be separated bynon-controllable sections. Moreover, one, several, or all thecontrollable sections (optionally including the remainder of elongatebody 14) may be rigidizable or shape-lockable by the user.

In the example of endoluminal tissue manipulation assembly 10, elongatebody may include a first articulatable section 24 located along elongatebody 14. This first section 24 may be configured via handle assembly 16to bend in a controlled manner within a first and/or second planerelative to elongate body 14. In yet another variation, elongate body 14may further comprise a second articulatable section 26 located distal offirst section 24. Second section 26 may be configured to bend orarticulate in multiple planes relative to elongate body 14 and firstsection 24. In yet another variation, elongate body 14 may furthercomprise a third articulatable section 28 located distal of secondsection 26 and third section 28 may be configured to articulate inmultiple planes as well, e.g., 4-way articulation, relative to first andsecond sections 24, 26.

As mentioned above, one or each of the articulatable sections 24, 26, 28and the rest of elongate body 14 may be configured to lock or shape-lockits configuration into a rigid set shape once the articulation has beendesirably configured. Detailed examples of such an apparatus having oneor multiple articulatable bending sections which may be selectivelyrigidized between a flexible configuration and a shape-lockedconfiguration may be seen, e.g., in U.S. Pat. Pub. Nos. 2004/0138525 A1,2004/0138529 A1, 2004/0249367 A1, and 2005/0065397 A1, each of which isincorporated herein by reference in its entirety. Although threearticulatable sections are shown and described, this is not intended tobe limiting as any number of articulatable sections may be incorporatedinto elongate body 14 as practicable and as desired.

Handle assembly 16 may be attached to the proximal end of elongate body14 via a permanent or releasable connection. Handle assembly 16 maygenerally include a handle grip 30 configured to be grasped comfortablyby the user and an optional rigidizing control 34 if the elongate body14 and if one or more of the articulatable sections are to berigidizable or shape-lockable. Rigidizing control 34 in this variationis shown as a levered mechanism rotatable about a pivot 36. Depressingcontrol 34 relative to handle 30 may compress the internal links withinelongate body 14 to thus rigidize or shape-lock a configuration of thebody while releasing control 34 relative to handle 30 may in turnrelease the internal links to allow the elongate body 14 to be in aflexible state. Further examples of rigidizing the elongate body 14and/or articulatable sections may again be seen in further detail inU.S. Pat. Pub. Nos. 2004/0138525 A1, 2004/0138529 A1, 2004/0249367 A1,and 2005/0065397 A1, incorporated above by reference. Although therigidizing control 34 is shown as a lever mechanism, this is merelyillustrative and is not intended to be limiting as other mechanisms forrigidizing an elongate body, as generally known, may also be utilizedand are intended to be within the scope of this disclosure.

Handle assembly 16 may further include a number of articulation controls32, as described in further detail below, to control the articulation ofone or more articulatable sections 24, 26, 28. Handle 16 may alsoinclude one or more ports 38 for use as insufflation and/or irrigationports, as so desired.

At the distal end of elongate body 14, end effector assembly 12 may bepositioned thereupon. In this variation, end effector assembly 12 mayinclude first tissue manipulation arm 20 and second tissue manipulationarm 22, each being independently or simultaneously articulatable andeach defining a lumen for the advancement of tools or instrumentstherethrough. Each of the tools or instruments may be advanced throughtool ports 40 located in handle assembly 16 to project fromarticulatable arms 20, 22 and controlled from handle assembly 16 orproximal to handle assembly 16. Alternatively, various tools orinstruments may be attached or connected directly to the distal ends ofarms 20, 22 and articulatable from handle assembly 16. At least one ofthe articulatable arms 20, 22 may be articulatable to reconfigure from alow-profile straightened configuration to a deployed configuration whereat least one of the arms 20, 22 is off-axis relative to a longitudinalaxis of elongate body 14. Various articulation and off-axisconfigurations for articulatable arms 20, 22 may be seen in furtherdetail in U.S. Pat. Pub. Nos. 2004/0138525 A1, 2004/0138529 A1,2004/0249367 A1, and 2005/0065397 A1, incorporated above by reference.

End effector assembly 12 may further include a visualization lumen orplatform 18 which may be articulatable into a deployed configurationsuch that a lumen opening or distal end of visualization lumen orplatform 18 is off-axis relative to the longitudinal axis of elongatebody 14, as described in further detail below.

FIGS. 2A and 2B show illustrative perspective views of a variation ofthe end effector assembly 12 in a deployed configuration and alow-profile delivery configuration, respectively. As seen in FIG. 2A,first and second articulatable arms 20, 22, respectively, may be seen inan off-axis configuration with a first tool 42, e.g., any conventionaltool such as a Maryland dissector, Babcock graspers, etc., advancedthrough first tool lumen 46 within first articulatable arm 20. Likewise,second articulatable arm 22 may have a second tool 44, e.g., anyconventional tool such as claw graspers, needle knife, etc., advancedthrough second tool lumen 48 within second articulatable arm 22. Firstand second tools 42, 44 may be articulated separately or simultaneouslyfor tissue manipulation and advanced freely distally and proximallythrough their respective tool lumens 46, 48.

Visualization lumen or platform 18 may also be seen in FIG. 2Aarticulated into its off-axis configuration relative to elongate body14. Visualization lumen opening 50 defined at the distal end ofvisualization platform 18 may be seen articulated into an off-axisconfiguration which directs visualization opening 50 such that thefield-of-view provided therefrom is directly over or upon an areaoccupied by the articulated tool arms 20, 22 and respective tools 46,48. Visualization from platform 18 may be provided by any number ofdifferent methods and devices. In a first example, visualization may beprovided by an endoscope 56 having imaging capabilities advanced throughelongate body 14 and through visualization platform 18. Imagingendoscope 56 may be advanced distally to project from lumen opening 50or it may be positioned within visualization platform 18 such that itsdistal end is proximal of or flush with lumen opening 50. Alternatively,imaging electronics such as CCD imaging chips or any other number ofimaging chips may be positioned within visualization platform 18 toprovide images of the field-of-view. These electronic images may betransmitted through wires proximally through elongate body 14 or theymay alternatively be transmitted wirelessly to a receiver locatedexternally of the patient body, as described below in further detail.

FIG. 2B shows the end effector assembly 12 in a low-profileconfiguration for endoluminal advancement through a patient body. Anatraumatic distal tip 54 may be provided over the distal end of elongatebody 14 and separate atraumatic distal tips 52 may also be provided aswell over the distal ends of first and second articulatable tool arms20, 22.

FIG. 3 shows a side view of the end effector assembly 12 of theapparatus of FIG. 2A. As illustrated, first and second tools 42, 44 maybe withdrawn into their respective tool lumens 46, 48 during endoluminaladvancement of elongate body 14 through the patient and advanced throughtool lumens 46, 48 prior to or after articulation of arms 20, 22.Likewise with visualization platform 18, if a visualization endoscope isadvanced therethrough, endoscope 56 may be positioned within platform 18during endoluminal advancement of elongate body 14 or after platform 18has been articulated.

FIGS. 4A and 4B show an example of the image which an off-axisvisualization platform 18 may provide during a tissue manipulationprocedure. As seen in FIG. 4A, the visualization image 60 as may be seenon a monitor by the physician during a procedure provides for anoff-axis view of the tissue region of interest as well as first andsecond tools 42, 44 and articulatable arms 20, 22. Such an “overhead”perspective enables the physician to gain an overview of the tissueregion of interest during a procedure and facilitates the procedure byfurther enabling the physician to triangulate the location of the tools42, 44 with respect to the tissue. Accordingly, manipulation of firsttissue region 64 and second tissue region 66 may be readily accomplishedby the physician while viewing the tissue region from off-axis platform18. As seen in the visualization image 62 in FIG. 4B, the tissue regions64, 66 may be manipulated by articulatable tool arms 20, 22, even whenthe tissue regions are approximated towards one another; such tissuemanipulation and visualization would generally be extremely difficult,if not impossible, using conventional endoscopic devices and tools whichare typically limited to straight-line tools and obstructed viewstypically afforded conventional endoscopes. The utilization of off-axisvisualization and off-axis tool articulation may thereby enable theeffective triangulation of various instruments to permit complex,two-handed tissue manipulations.

The end effector assembly 12 may accordingly be utilized to facilitateany number of advanced endoluminal procedures, e.g., extended mucosalresection, full-thickness resection of gastric and colonic lesions, andgastric remodeling, among other procedures. Moreover, assembly 10 may beutilized in procedures, e.g., trans-luminal interventions to performorgan resection, anastomosis, gastric bypass or other surgicalindications within the peritoneal cavity, etc.

Referring now to FIG. 5, another variation is described wherein thearticulating element comprises a steerable shaft. Visualization assembly70 may generally comprise elongate body 72 having longitudinal axis W,distal region 73 and lumen 74. As mentioned above, elongate body 72 maycomprise a rigidizable and/or articulatable body or it may comprise apassively flexible body. Assembly 70 further may further comprisearticulating element or platform 80 disposed near distal region 73 ofelongate body 72. Platform 80 may be coupled to the elongate body bylinkages 96 a, 96 b rotatably disposed between hinges 92 a, 94 a and 92b, 94 b, respectively. Articulating platform 80 via hinges 92 a, 94 aand 92 b, 94 b may allow for lumens or lumen 74 to be unobstructed withthe platform 80 articulated away from the openings. Visualizationassembly 70 may be seen in further detail in U.S. patent applicationSer. No. 10/824,936, which has been incorporated herein above byreference.

Articulating platform 80 may further comprise articulatablevisualization lumen 82. Visualization lumen 82 may be passivelyarticulatable or, alternatively, may be actively controllable. Anynumber of conventional methods may be utilized to articulate the shapeand configuration of lumen 82. In FIG. 5, lumen 82 illustratively may,for example, be steerable in any number of directions. In thisvariation, lumen 82 may be steerable in at least four directions, e.g.,via four control wires routed through or along cable 84 and elongatebody 72 to a proximal region of assembly 70 for manipulation by amedical practitioner. Cable 84 may also be used to articulate platform80. The control wires for steerable lumen 82 may be routed through oralong body 72 in spaces that would not be usable as working lumens orfor tool insertion.

During delivery, articulating platform 80 and steerable lumen 82 aretypically aligned with axis W of elongate body 72. Advantageously, theability to articulate platform 80 off-axis post-delivery allows assembly70 to have both a large working lumen 74 and a small collapsed deliveryprofile. Furthermore, steerable platform 82 gives the assembly anoff-axis platform with added functionality for performing complexprocedures. The steering capability of lumen 82 may be used to steertherapeutic or diagnostic tools, and/or for illumination, visualization,fluid flushing, suction, etc., into better position for conducting suchprocedures.

Various methods and apparatus for controlling elements used inconjunction with lumen 82 may be routed through cable 84 along with thecontrol wires for lumen 82. For example, when a visualization element iscoupled to steerable shaft 82, electrical wires may run through cable 84for sending and/or receiving signals, power, etc., to/from thevisualization element. In such a variation, the visualization elementwould allow direct visualization during insertion within a body lumen,while providing off-axis visualization and steering, as well asfacilitating tool introduction, post-articulation. Alternatively oradditionally, when a working lumen is disposed through steerable lumen82, cable 84 may comprise a lumen for connecting the shaft lumen to alumen extending through elongate body 72 of assembly 70 through whichany number of visualization instruments may be advanced through.

Alternatively or additionally, various imaging modalities, such as CCDchips and LED lighting may also be positioned within or upon lumen 82.In yet another alternative, an imaging chip may be disposed orpositioned upon or near the distal end of lumen 82 to provide forwireless transmission of images during advancement of assembly 70 into apatient and during a procedure. The wireless imager may wirelesslytransmit images to a receiving unit RX located externally to a patientfor visualization.

Referring now to FIG. 6, an alternative variation of assembly 70 isshown comprising multiple articulating elements having steerable shafts.Assembly 70′ may comprise first articulating platform 80 a and secondarticulating platform 80 b. Platform 80 may comprise first steerablelumen 82 a and second steerable lumen 82 b, respectively. Lumens 74 aand 74 b extend through elongate body 72′ and are exposed uponarticulation of platform 80 a and 80 b, respectively. As will beapparent, a single lumen or more than two lumens alternatively may beprovided. Likewise, more than two articulating elements and/or steerableshafts optionally may be provided.

First steerable lumen 82 a illustratively is shown with working lumen 86that extends through the lumen, as well as through cable 84 a andelongate body 72′. Exemplary grasper tool 90 is shown advanced throughlumen 86. Second steerable lumen 82 b illustratively is shown withvisualization element 88, as previously described, coupled to an endthereof. Electrical wires, e.g., for powering and transmitting signalsto/from the visualization element, may be disposed within cable 84 b. Aswill be apparent, steerable lumens 82 may be provided with additional oralternative capabilities. In the case of visualization element 88 beinga wireless imager, electrical wires may be omitted altogether.

With reference to FIGS. 7 and 8, illustrative embodiments of atraumatictips for use with the assembly 70 are described. As shown in FIG. 7,assembly 70 is shown with atraumatic tip 76. Tip 76 provides a smoothtransition between elongate body 72 and articulating platform 80 withsteerable lumen 82. Tip 76 may, for example, comprise an inflatableballoon 77 that may be inflated as shown during insertion and deliveryof assembly 70, then deflated prior to articulation of platform 80 andoff-axis steering of lumen 82, so as not to block or impede articulationor the distal opening of the lumen 74 post-articulation.

In FIG. 8, assembly 100 may comprise an alternative atraumatic tip 78having cap 79, which optionally may be fabricated from rubber. Cap 79may be U-shaped to both provide a smooth transition between elongatebody 102 and articulating platform 106 in the delivery configuration, aswell as to ensure that the cap does not block or impede lumen 104post-articulation.

FIGS. 9 and 10 show additional alternative configurations of thearticulatable platform and visualization lumen. Articulatablevisualization lumen 110 may be manipulated to articulate in an off-axisconfiguration such that visualization lumen opening 112 is directed toface in a direction which is off-axis relative to a longitudinal axis ofelongate body 72 and which is also perpendicular relative to thelongitudinal axis. Although visualization lumen 110 may be articulatedto face any number of directions, such a configuration may allow for avisualization element positioned within opening 112 to directly faceover or upon the tissue region of interest, if so desired.

As shown in FIG. 9, visualization lumen 110 may be positioned uponplatform 80 and articulated via linkages 96 a, 96 b, as described above.Alternatively, visualization lumen 110 may also be directly attached viainterface 114 to elongate body 72 and articulated therefrom, also asdescribed above.

Turning now to the elongate body, FIG. 11 illustrates one variation forassembly of the elongate body 120. Distal end effector assembly 12 hasbeen omitted merely for the sake of clarity from FIG. 11 and followingfigures. The elongate body 120 may have a single lumen therethrough fora variety of uses, such as for passage of one or more instruments or forthe passage of air or fluid, such as for aspiration or suction.Similarly, the elongate body 120 may have more than one lumen passingtherethrough, each lumen used for a different function.

Further details of the elongate body construction may be seen in any ofthe following U.S. Pat. Pubs. 2004/0138525 A1; 2004/0138529 A1;2004/0249367 A1; and 2005/0065397 A1, each of which is incorporatedherein by reference in its entirety.

In some variations, elongate body 120 may include at least oneinstrument or tool lumen 130, e.g. an arm guide lumen, which extendsover or through at least a distal section of the elongate body 120,typically along the majority of the length of the body 120 as shown.Here in FIG. 11, two arm guide lumens 130 are shown, each extending froma position along the shaft 120 near the proximal end 122 to the distaltip 126. In addition, the elongate body 120 includes a visualizationlumen 128, which extends through the shaft 120 to the distal tip 126.

In some variations, the assembly also includes at least one tool arm132, two are shown in FIG. 11, each arm 132 of which is insertablethrough a separate arm guide lumen 130 as indicated by the dashed lines.Each tool arm 132 has a proximal end 134, a distal end 136 and a shaft140 therebetween. The distal end 136 optionally is steerable, such as bymanipulation of adjacent links as schematically indicated. Suchsteerability may be controlled by any number of methods, e.g., asteering cuff 138, which is part of the proximal end 134. The shaft 140is typically flexible or deflectable to allow deflection of thesurrounding elongate body shaft 120. Each tool arm 132 may additionallyinclude a tool deployment lumen 142 therethrough.

Elongate body 120 includes at least one tool 144 with two tools 144shown in FIG. 11. Each tool 144 includes a distal end 146, a proximalend 148 and an elongate shaft 150 therebetween to allow passage throughthe tool deployment lumen 142 of the tool arm 132, or through lumen 130of elongate body 120. Each tool 144 has an end effector 152 disposed atthe distal end 146 and optionally a handle 154 at the proximal end 148for manipulation of the end effector 152 from outside the body. The tool144 is advanced so that the end effector 152 emerges from the distal end136 of the arm 132, or from distal tip 126 of elongate body 120. As willbe apparent, tool 144 optionally may be formed integrally with tool arm132. Accordingly, rather than utilizing one or more tool arm shafts 140insertable through elongate body 120, articulatable distal ends 136 mayalternatively be connected directly near or at the distal tip 126 ofelongate body 120. Additionally, the distal ends of tools 144 may alsobe connected directly to articulatable distal ends 136.

FIG. 12 illustrates the assembly of FIG. 11 in an exemplary assembledarrangement. Here, the tool arms 132 are shown inserted through the armguide lumens 130 of the elongate body shaft 120. The steerable distalends 136 of the arms 132 protrude from the distal end 124 of theelongate body 120 and the proximal ends 134 of the arms 132 protrudefrom the proximal end 122 of the elongate body 120. Additionally, thetools 144 are shown inserted through the tool deployment lumens 142 sothat the end effectors 152 extend beyond the steerable distal ends 136of the arms. Likewise, the proximal ends 148 of the tools 144 withhandles 154 may protrude proximally from the assembly. As describedabove, the articulatable visualization lumen 18 or 110 (omitted from thefigure for clarity) may be connected to the distal end of 124 ofelongate body 120 at the location of lumen 128. Alternatively, anendoscope used for visualization may be routed directly through lumen128.

FIGS. 13A to 13D illustrate a series of movements of the steerabledistal ends 136 of the tool arms 132. This series serves only as anexample, as a multitude of movements may be achieved by the distal ends136 independently or together. Moreover, articulatable visualizationlumen or platform 18 or 110 has been omitted from the illustrationsmerely for the sake of clarity. FIG. 13A illustrates the distal tip 126of the elongate body 120. The visualization lumen 128 is shown alongwith two arm guide lumens 130. FIG. 13B illustrates the advancement ofthe distal ends 136 of the tool arms 132 through the arm guide lumens130 so that the arms 132 extend beyond the distal tip 126.

FIGS. 13C and 13D illustrate deflection of the arms 132 to an exemplaryarrangement. FIG. 13C illustrates deflection of the arms 132 laterallyoutward. This may be achieved by curvature in the outward direction nearthe base 156 of the steerable distal end 136. FIG. 13D illustratesdeflection of the tip section 158 of the distal end 136 laterally inwardachieved by curvature in the inward direction. When an imager 162 ispositioned within the lumen 128, the tip sections 158 of the tool arms132 and any tools 144 advanced therethrough, will be visible through theimager 162. Additionally, when articulatable visualization lumen 18 or110 is positioned within or connected to lumen 128, articulation of thevisualization lumen into its off-axis configuration will bring tools132, and in particular the distal ends 136 of tool arms 132 into thefield-of-view, as described above. In FIGS. 13C and 13D, deflection ofthe arms 132 may be achieved with the use of adjacent links 160 in theareas of desired curvature.

Variations of such links 160 and other mechanisms of deflection aredescribed in further detail in U.S. Pat. Pubs. 2004/0138525 A1;2004/0138529 A1; 2004/0249367 A1; and 2005/0065397 A1, each of which hasbeen incorporated above herein by reference. Further, the deflectionshown in FIGS. 13A to 13D are shown to be within a single plane.However, variations include deflection in multiple planes. Likewise, thearms 132 are shown to be deflected simultaneously in FIGS. 13A to 13D,however the arms 132 may be deflected selectively or independently.

FIGS. 14 to 16 illustrate additional possible movements of the tool arms132. For example, FIG. 14 illustrates possible axial movement of thetool arms 132. Each tool arm 132 can independently move distally orproximally, such as by sliding within the tool deployment lumen 142, asindicated by the arrows. Such movement may maintain the arms 132 withinthe same plane, yet allows more diversity of movement and thereforesurgical manipulations. FIG. 15 illustrates rotational movement of thetool arms 132. Each tool arm 132 can independently rotate, such as byrotation of the arm 132 within the tool deployment lumen 142, asindicated by circular arrow. Such rotation may move the arm or arms 132through a variety of planes. By combining axial, lateral and rotationalmovement, the arms 132, and therefore the tools 144 positionedtherethrough (or formed integrally therewith), may be manipulatedthrough a wide variety of positions in one or more planes.

FIG. 16 illustrates further articulation of the tool arms 132. In somevariations, the arms 132 may be deflectable to form a predeterminedarrangement. Typically, when forming a predetermined arrangement, thearms 132 are steerable up until the formation of the predeterminedarrangement wherein the arms 132 are then restricted from furtherdeflection. In other variations, the arms 132 may be deflectable to avariety of positions and are not limited by a predetermined arrangement.Such an example is illustrated in FIG. 16 wherein the arms 132articulate so that the tip sections 158 curl inwardly. The tip sections158 may be positioned in front of the lumen 128 and imager 162 forviewing or within the field-of-view provided by the off-axisarticulation of visualization lumen 18 or 110 (omitted for clarity).Typically, the tip sections 158 may be positioned on opposite sides of alongitudinal axis 166 of the elongate body 120, wherein for an imager166 positioned within lumen 128, in one variation, the field-of-view(indicated by arrow 164) may span up to, e.g., approximately 140degrees.

FIGS. 17A and 17B illustrate one example for use of the endoluminalassembly 10. FIG. 17A illustrates advancement of the elongate body 120through the esophagus E to the stomach S, as shown in FIG. 17A. Theelongate body 120 may then be steered to a desired position within thestomach S, and a tissue region of interest M may be visualized byvisualization lumen or platform 18, which may be articulated into itsoff-axis configuration, as shown in FIG. 17B. Tool arms 132 may also beadvanced, if not already attached directly to the distal end of elongatebody 120, through the elongate body 120 and articulated. As previouslydescribed, one or several tools 144 may be advanced through the toolarms 132, or an end effector 152 may be disposed at the distal end ofeach arm 132. In this example, a grasper 168 is disposed at the distalend of one arm 132 and a cutter 81 is disposed at the distal end of theother arm 132, although any number of tools, e.g., graspers, biopsygraspers, needle knives, snares, etc., may be utilized depending uponthe desired procedure to be performed. Moreover, the tools 144 mayalternatively be affixed upon the distal ends of tool arms 132 andatraumatic tips may be provided thereupon to prevent trauma to contactedtissue during endoluminal advancement.

It may be appreciated that the systems, methods and devices of thepresent invention are applicable to diagnostic and surgical proceduresin any location within a body, particularly any natural or artificiallycreated body cavity. Such locations may be disposed within thegastrointestinal tract, urology tract, peritoneal cavity, cardiovascularsystem, respiratory system, trachea, sinus cavity, female reproductivesystem and spinal canal, to name a few. Access to these locations may beachieved through any body lumen or through solid tissue. For example,the stomach may be accessed through an esophageal or a port accessapproach, the heart through a port access approach, the rectum through arectal approach, the uterus through a vaginal approach, the spinalcolumn through a port access approach and the abdomen through a portaccess approach.

A variety of procedures may be performed with the systems and devices ofthe present invention. The following procedures are intended to providesuggestions for use and are by no means considered to limit such usage:laryngoscopy, rhinoscopy, pharyngoscopy, bronchoscopy, sigmoidoscopy,colonoscopy, esophagogastroduodenoscopy (EGD) which enables thephysician to look inside the esophagus, stomach, and duodenum.

In addition, endoscopic retrograde cholangiopancreatography (ERCP) maybe achieved which enables the surgeon to diagnose disease in the liver,gallbladder, bile ducts, and pancreas. In combination with this processendoscopic sphincterotomy can be done for facilitating ductal stoneremoval. ERCP may be important for identification of abnormalities inthe pancreatic and biliary ductal system. Other treatments includecholecystectomy (removal of diseased gallbladder), CBD exploration (forcommon bile duct stones), appendicectomy (removal of diseased appendix),hernia repair TAP, TEPP and other (all kinds of hernia), fundoplicationand HISS procedures (for gastro esophageal reflux disease), repair ofduodenal perforation, gastrostomy for palliative management of latestage upper G.I.T. carcinoma), selective vagotomy (for peptic ulcerdisease), splenectomy (removal of diseased spleen), upper and lower G.I.endoscopies (diagnostic as well as therapeutic endoscopies),pyloroplastic procedures (for children's congenital deformities),colostomy, colectomy, adrenalectomy (removal of adrenal gland forpheochromocytoma), liver biopsy, gastrojejunostomy, subtotal liverresection, gastrectomy, small intestine partial resections (forinfarction or stenosis or obstruction), adhesions removal, treatment ofrectum prolaps, Heller's Myotomy, devascularization in portalhypertension, attaching a device to a tissue wall and local drugdelivery to name a few.

As mentioned previously, elongate body 120 has a proximal end 122 and adistal end 124 terminating in a distal tip 126. Elongate body 120 mayinclude one or more sections or portions of elongate body 120 in whicheach section may be configured to bend or articulate in a controlledmanner. A first section along elongate body 120 may be adapted to bedeflectable and/or steerable, shape-lockable, etc. A second section,which may be located distally of and optionally adjacent to the firstsection along elongate body 120, may be adapted to retroflex independentof in conjunction with the first section. In one variation, this secondsection may be laterally stabilized and deflectable in a single plane.An optional third section, which may be located distally of andoptionally adjacent to the second section, may be adapted to be asteerable portion, e.g., steerable within any axial plane in a360-degree circumference around the shaft.

When a third section is utilized as the most distal section alongelongate body 120, such steerability may allow for movement of thedistal tip of elongate body 120 in a variety of directions. Suchsections will be further described below. It may be appreciated that theelongate body 120 may be comprised of any combination of sections andmay include such sections in any arrangement. Likewise, the elongatebody 120 may be comprised of any subset of the three sections, e.g.,first section and third section, or simply a third section. Further,additional sections may be present other than the three sectionsdescribed above. Furthermore, multiple sections of a given variety, e.g.multiple sections adapted to be articulated as second section above, maybe provided. Finally, one or all three sections may be independentlylockable, as will be described below.

One variation of the elongate body 120 is illustrated in FIG. 18A in astraightened configuration. Only elongate body 120 is shown in theseillustrations and the end effector assembly with off-axis tool arms andoff-axis visualization has been omitted merely for the sake of clarity.Because the elongate body 120 is used to access an internal targetlocation within a patient's body, elongate body 120 may include adeflectable and/or steerable shaft 120. Thus, FIG. 18B illustrates theelongate body 120 having various curvatures in its deflected or steeredstate. The elongate body 120 may be steerable so that the elongate body120 may be advanced through unsupported anatomy and directed to desiredlocations within hollow body cavities. In this example, the elongatebody 120 includes a first section 180 which is proximal to a secondsection 182, as indicated in FIG. 18B. Although both sections 180, 182may be steerable, first section 180 may be adapted to lock itsconfiguration while the second section 182 is further articulatable, asillustrated in FIG. 18C where first section 180 is shown in a lockedposition and the second section 182 is shown in various retroflexedpositions.

When retroflexed, second section 182 may be curved or curled laterallyoutwardly so that the distal tip 126 is directable toward the proximalend 122 of the elongate body 120. Moreover, the second section 182 maybe configured to form an arc which traverses approximately 270 degrees,if so desired. Optionally, the second section 182 also may be locked,either when retroflexed or in any other position. As should beunderstood, first section 180 optionally may not be steerable orlockable. For example, section 180 may comprise a passive tubeextrusion.

A further variation of elongate body 120 is illustrated in FIG. 18D, ina straight configuration, and in FIG. 18E, in a deflected or steeredstate having various curvatures. In this variation, elongate body 120may include a first section 180 proximal to a second section 182, whichis proximal to a third section 184. First section 180 may be flexible orsemi-flexible, e.g. such that the section 180 is primarily moveablethrough supported anatomy, or is moveable through unsupported anatomyvia one or more stiffening members disposed within or about the section.The first section 180 may be comprised of links or nestable elementswhich may enable the first section 180 to alternate between a flexiblestate and a rigidized stated.

Optionally, first section 180 may comprise locking features for lockingthe section in place while the second section 182 is furtherarticulated. Typically, the second section 182 may be configured to beadapted for retroflexion. In retroflexion, as illustrated in FIG. 18E,second section 182 may be curved or curled laterally and outwardly sothat a portion of second section 182 is directed toward the proximal end122 of the elongate body 120. It may be appreciated that second section182 may be retroflexed in any desired direction. Optionally, secondsection 182 may also be locked, either in retroflexion or in any otherposition.

Further, first section 180 and second section 182 may be locked in placewhile third section 184 is further articulated. Such articulation istypically achieved by steering, such as with the use of pullwires. Thedistal tip 126 preferably may be steered in any direction relative tosecond section 182. For example, with second section 182 defining anaxis, third section 184 may move within an axial plane, such as in awagging motion. The third section 184 may move through any axial planein a 360 degree circumference around the axis; thus, third section 184may be articulated to wag in any direction. Further, third section 184may be further steerable to direct the distal tip 126 within any planeperpendicular to any of the axial planes. Thus, rather than wagging, thedistal tip 126 may be moved in a radial manner, such as to form a circlearound the axis. FIG. 18E illustrates third section 184 steered into anarticulated position within an axial plane.

The variation of elongate body 120 illustrated in FIGS. 18D and 18Ehaving three sections 180, 182, 184 with varying movement capabilitiesare shown in FIGS. 18F and 18H in an example of positioning elongatebody 120 within a stomach S through an esophagus E. Since elongate body120 may be deflectable and at least some of the sections 180, 182, 184may be steerable, elongate body 120 may be advanced through the tortuousor unpredictably supported anatomy of the esophagus and into the stomachS while reducing a risk of distending or injuring the organs, as shownin FIG. 18F. Once the distal tip 126 has entered the stomach, secondsection 182 may be retroflexed as illustrated in FIG. 18G. Duringretroflexion, distal tip 126 may traverse an arc having a continuousradius of curvature, e.g., approximately 270 degrees with a radius ofcurvature between about 5 to 10 cm. By retroflexing, distal tip 126 maybe directed back towards first section 180 near and inferior togastroesophageal junction GE. Second section 182 may be activelyretroflexed, e.g. via pullwires, or it may be passively retroflexed bydeflecting the section off a wall of stomach S while advancing elongatebody 120.

Second section 182 may be configured to be shape-lockable in theretroflexed configuration. The distal tip 126 may then be furtherarticulated and directed to a specific target location within thestomach. For example, as shown in FIG. 18H, the distal tip 126 may besteered toward a particular portion of the gastroesophageal junction GE.Third section 184 may optionally be shape-locked in this configuration.Off-axis tools and off-axis visualization may then be deployed throughor from elongate body 120, as described above, to perform any number ofprocedures.

FIG. 18I shows yet another example in which elongate body 120 may bearticulated in a manner similar as shown above in FIG. 18H. In thisvariation, elongate body may comprise a first section 180 which isconfigured to bend or curve in any number of directions. One particularvariation may configure first section 180 to articulate in a directionopposite to a direction in which second section 182 bends. This opposedarticulation may result in an elongate body 120 which conforms into aquestion-mark shape to facilitate positioning of third section 184within stomach S, particularly for procedures which may be performednear or at the gastroesophageal junction GE. First section 180 may beconfigured to automatically conform into its opposed configuration uponrigidizing elongate body 120 or it may alternatively be articulated intoits configuration by the physician.

Turning now to the construction of the individual links which may formelongate body, FIGS. 19, 20A, and 20B show examples of link variationswhich may be utilized. FIGS. 20A and 20B show end and side views,respectively, of one variation of a link which may be utilized forconstruction of elongate body 120. An exemplary elongate body link 200may be comprised generally of an open lumen 202 through any number ofseparate lumens, e.g., tool arm lumens, visualization lumens, etc., maybe routed through.

The periphery defining open lumen 202 may define a number of openingsfor passage of various control wires, cables, optical fibers, etc. Forinstance, control wire lumens 204 may be formed at uniform intervalsaround the link 200, e.g., in this example, there are four control wirelumens 204 shown uniformly positioned about the link 200, although anynumber of lumens may be utilized as practicable and depending upon thedesired articulation of elongate body 120. Elongate body link 200 mayalso comprise a number of auxiliary control lumens 206 spaced aroundbody link 200 and adjacent to control wire lumens 204. Any number ofbiocompatible materials may be utilized in the construction of links200, e.g., titanium, stainless steel, etc.

Aside from the elongate body links 200, one variation for a terminallink 190 may be seen in FIG. 19. Terminal link 190 may be utilized as aninterface link between elongate body 120 and the distal end effectorassembly 12. In the variation shown in FIG. 19, three lumens areutilized in terminal link 190 for a visualization lumen 192 and two toolarm channels 194, 196. In other variations for the terminal link,additional lumens may be defined through the link. In the case of an endeffector having tools and a visualization lumen attached or coupleddirectly to the distal end of elongate body 120, the off-axis tools armsand off-axis articulatable lumen may be connected directly to terminallink 190.

Further examples and details of link construction may be seen in furtherdetail in U.S. Pat. Pubs. 2004/0138525 A1; 2004/0138529 A1; 2004/0249367A1; and 2005/0065397 A1, each of which has been incorporated aboveherein by reference.

Arrangement of the individual lumens routed through elongate body 120may be accomplished in any number of ways. For example, FIGS. 21A and21B show end views of possible lumen arrangements where four lumens areutilized through elongate body 120. The variation in FIG. 21A showselongate body link 200 where visualization lumen 192 and auxiliaryinstrument lumen 208 may be of a similar size diameter. Lumens 192, 208may be positioned adjacently to one another with tool arm channels 194,196 positioned on either side of lumens 192, 208.

In another variation, auxiliary instrument lumen 208 may be adjacentlypositioned and larger than visualization lumen 192, in which case toolarm channels 194, 196 may be positioned on either side of visualizationlumen 192. In the spaces or interstices through link 200 between thevisualization lumen 192, auxiliary instrument lumen 208, or either toolarm channels 194, 196, multiple smaller diameter lumens may be routedthrough for any number of additional features, e.g., insufflation,suction, fluid delivery, etc. FIG. 21C shows a perspective view of asingle elongate body link 200 with visualization lumen 192, auxiliaryinstrument lumen 200, and tool arm channels 194, 196 routedtherethrough.

Turning now to the handle for endoluminal assembly 10, one variation ofhandle assembly may be seen in the perspective views of FIGS. 22A and22B. Handle assembly 16 may generally comprise, in one variation, handle30 which is connectable to the proximal end of elongate body 120 viaelongate body interface 210. Coupling between the elongate body 120 andinterface 210 may be accomplished in a number of different ways, e.g.,interference fit, detents, etc., or the proximal link of elongate body120 and interface 210 may be held adjacently to one another by routingcontrol wires from handle 30 through interface 210 and into elongatebody 120.

Interface 210 may also be adapted to travel proximally or distallyrelative to handle 30 when rigidizing control 34 is actuated about pivot36 to actuate a rigidized or shape-locked configuration in elongate body120. An example is shown in FIG. 22A where control 34 is depressedagainst handle 30 to advance interface 210 distally from handle 30. Thisdistal movement of interface 210 compresses the links throughoutelongate body 120 to rigidize its configuration. Likewise, as shown inFIG. 22B, when control 34 is released or pivoted away from handle 30,interface 210 may be configured to travel proximally relative to handle30 such that a connected elongate body 120 is released into a flexiblestate by decompression of its links. Further details of mechanisms andmethods for link compression for actuating a rigid shape of elongatebody 120 may be seen further detail in U.S. Pat. Nos. 6,783,491;6,790,173; and 6,837,847, each of which has been incorporated byreference above.

Handle 30 may also define an elongate body entry lumen 212 which may bedefined near or at a proximal end of handle 30. Entry lumen 212 maydefine one or more openings for the passage of any of the tools andinstruments, as described herein, through handle 30 and into elongatebody 120. One or more ports, e.g., ports 214, 216, which are in fluidcommunication with one or more lumens routed through elongate body 120,as described above, may also be positioned on handle 30 and used forvarious purposes, e.g., insufflation, suction, irrigation, etc.

Additionally, handle 30 may further include a number of articulation ormanipulation controls 32 for controlling elongate body 120 and/or endeffector assembly 12. As shown in FIGS. 22A and 22B, control assembly 32in this variation may include a first control 218 for manipulating orarticulating first section 180; a second control 220 for manipulating orarticulating second section 182 in a first plane; and a third control222 for manipulating or articulating second section 182 in a secondplane. In this variation of handle assembly 16, control assembly 32 isconfigured to have several control wheels which are adjacentlypositioned relative to one another over a common control axis 224, asshown in the end view of handle assembly 16 in FIG. 22C. Controlassembly 32 may also include a locking mechanism 226 which may beconfigured to lock each of the controls 218, 220, 222 individually orsimultaneously to lock a configuration of each section.

Moreover, each of the controls 218, 220, 222 may be configured toarticulate their respective sections along elongate body 120 even whenrigidizing control 34 has been articulated to rigidize a shape of theelongate body 120. In alternative variations, handle assembly 16 mayinclude additional controls for additional sections of elongate body120. Moreover, alternative configurations for the control assembly 32may also include articulating levers or sliding mechanisms along handle30 as control wheels are intended to be merely illustrative of the typeof control mechanisms which may be utilized.

As mentioned above, entry lumen 212 may define one or more openings forthe passage of any of the tools and instruments, as described herein,through handle 30 and into elongate body 120. To manage the insertionand sealing of multiple lumens routed through handle assembly 16 andelongate body 120, a port assembly may be connected or attached tohandle 30 proximally of entry lumen 212 in a fluid-tight seal. A portassembly alignment post 228 for aligning such a port assembly may beseen in the end view of FIG. 22C. An example of such a port assembly 230is shown in the perspective view of FIG. 23. Port assembly 230 may beseen having a visualization port lumen 232 for the insertion and passageof a visualization tool, as well as tool ports 234, 236 on either sideof visualization port lumen 232 for the insertion of tools, as describedabove. Auxiliary instrument port 238 may also be seen on port assembly230.

To maintain a fluid-tight seal through handle assembly 16 and elongatebody 120 during instrument insertion, movement, and withdrawal in thepatient body, a removable gasket 240 made from a compliant material,e.g., polyurethane, rubber, silicon, etc., may be positioned betweenports 232, 234, 236, 238 of port assembly 230 and a retainer forsecurely retaining the gasket against assembly 230. The retainer mayalso have ports 232′, 234′, 236′, 238′ defined therethrough foralignment with their respective ports in assembly 230 for passage of thetools or instruments.

Other configurations for the end effector assembly may also be madeutilizing a number of variations. FIGS. 24A and 24B show perspective andpartial cross-sectional views, respectively, of a variation of endeffector assembly 250. As illustrated, elongate body 252 may be ashape-lockable or rigidizable body which may be steerable ornon-steerable, as described above, or it may generally be a passivelyflexible body which may be steerable or non-steerable as well. In eithercase, an opening 254 may be defined through an outer surface near or ata distal end of elongate body 252.

A visualization assembly 256, which may generally comprise an endoscope258 having a bendable or flexible section 260 near or at its distal end,may be advanced through an endoscope or auxiliary instrument lumen 272defined through elongate body 252 and advanced through opening 254.Endoscope 258 may be advanced through opening 254 such that its flexiblesection 260 enables the end of endoscope 258 to be positioned in anoff-axis configuration distal of elongate body 252. Alternatively,endoscope 258 may be advanced entirely through lumen 272 such that it isdisposed at the distal end of lumen 272 or projects distally therefromto provide visualization of the tissue region of interest. First andsecond articulatable tool arms 262, 264 having one or more tools 266upon their respective distal ends, as described above, may also beadvanced through respective first and second tool lumens 268, 270. Toolarms 262, 264 may be disposed distally of elongate body 252 such thatthey are within the visualization field provided by the off-axisendoscope 258.

In another variation as shown in FIGS. 25A and 25B, elongate body 274may comprise bendable or articulatable sections of varying lengths.Elongate body 274 in this variation may be shape-lockable or rigidizablealong its length, as above, or it may have a passively flexible length.For example, elongate body 252 may have a first section 276 having alength D1 and a second section 278 having a length D2 located distallyof first section 276. In the example shown, the length D1 of firstsection 276 may be shorter than the length D2 of second section 278,although the length of D1 may be longer than D2 in another alternative.Moreover, in yet another alternative, the lengths D1 and D2 may beequal. In the variation shown, having a length of D1 shorter than lengthD2 may allow for the end effector assembly to be articulated into avariety of configurations, especially if first section 276 isarticulated in a direction opposite to a direction in which secondsection 278 is articulated, as shown in FIG. 25B. Any of the endeffector assemblies described herein may be utilized with elongate body252 having various lengths of sections 276, 278.

FIG. 26 shows a side profile of end effector assembly 280 in yet anothervariation. As shown, end effector assembly 280 may have an optionallyshape-lockable elongate body 282 with articulatable first section 284and second section 286. Second section 286 may be articulatable into anoff-axis configuration such that an imager 288 positioned at its distalend may become positioned to view a region of interest accessible byfirst and second tool arms 292, 294, which may be passed throughelongate body 282 and through opening 290 defined in first section 284into the field-of-view provided by off-axis imager 288. Tool arms 292,294 may be articulatable tool arms, as described above, or they maycomprise any manner of conventional in-line tools.

In yet another variation, FIGS. 27A and 27B show perspective views ofend effector assembly 300 which may optionally comprise a shape-lockableelongate body 302 with off-axis visualization assembly 256, as above. Inthis variation, first and second tool arms 304, 306, respectively, maycomprise arm members each having a first and second preset bendingportion 308, 310, respectively, each configured to bend at a presetangle once free from the constraints of the tool lumens, as shown inFIG. 27B. Once unconstrained, tools arms 304, 306 may be rotated aboutits longitudinal axis, as shown in FIG. 27C, to accomplish any number ofprocedures on the tissue while visualized via off-axis endoscope 258.Tool arms 304, 306 may be fabricated from shape memory alloys, such as aNickel-Titanium alloy, or from spring stainless steels, or any othersuitable material which may allow for the tools arms 304, 306 toreconfigure itself from a first low-profile configuration to an off-axisdeployment configuration.

FIG. 27D shows a perspective view of yet another variation in whichelongate body 302 may have first and second articulatable tool arms 312,314 which are freely rotatable about their respective longitudinal axes.Visualization assembly 256 may comprise any of the variations describedabove, particularly the variation as described for FIGS. 24A and 24B.

FIG. 28 shows a perspective view of another variation of end effectorassembly 320 in which optionally shape-lockable elongate body 322 maycomprise a separate visualization lumen 324 having a lumen opening 326through which a guidewire 328 having a preset configuration may beadvanced. Visualization lumen 324 may be integrated with elongate body322 or separately attached to an outer surface of elongate body 322.Guidewire 328 may be comprised of a shape memory alloy, as above, andcarry an imaging chip 330, e.g., a CCD imager, on a distal end of theguidewire 328. Guidewire 328 may be preset to reconfigure itself into anoff-axis configuration to provide the off-axis visualization distally ofelongate body 322, as shown. Furthermore, imaging chip 330 may beconnected via wires through guidewire 328 to a monitor at a locationproximal to elongate body 322 or imaging chip 330 may be adapted towirelessly transmit images to a receiving unit external to a patientbody. Moreover, guidewire 328 may also be advanced through a workinglumen of elongate body 322 if so desired.

In another alternative, end effector assembly 340 shown in FIG. 29 maycomprise an optionally shape-lockable body 342 having visualizationmember 344 pivotably mounted near or at a distal end of body 342 viapivot 348. Visualization member 344 may have an imager 346, e.g., animaging chip such as a CCD chip, positioned upon a distal end of member344, which may be configured to articulate about pivot 348 such thatimager 346 is provided an off-axis view of the region distal of elongatebody 342.

In another variation, the off-axis visualization may be provided, e.g.,within the stomach S, via one or more capsules 350 having integratedimagers 352 positioned within one or more regions of the stomach S.Rather than, or in combination with, off-axis visualization lumen orplatform 18, a number of imaging capsules 350 may be temporarily adheredto the interior stomach wall, e.g., via clips 354 attached to thecapsule body. The imaging portions 352 of the capsules 350 may bepositioned against the stomach wall such that one or more capsules 350are pointed towards a tissue region of interest. The endoluminalassembly 10 may then be articulated towards the tissue region ofinterest with either off-axis visualization platform 18 or one or morecapsules 350 providing a number of off-axis views for any number ofprocedures to be accomplished. Imaging capsules such as the PillCam™ aregenerally used for capsule endoscopy and may be commercially obtainedfrom companies like Given Imaging Ltd. (Israel).

Turning now to FIGS. 31A and 31B, imaging assembly or endoscope 370 maybe advanced through visualization lumen 364, which runs throughoptionally rigidizable elongate body 360, and passed through opening orskive 362 defined along the outer surface near the distal end ofelongate body 360. Imaging assembly 370 may be alternatively passeddistally through visualization lumen 364 to the opening defined throughthe atraumatic distal end 368. When positioned through skive 362,imaging assembly 370 may be articulated into an off-axis configurationrelative to the longitudinal axis of elongate body 360 such that theimaging element at its distal end is directed to the area distal to theelongate body 360 along its longitudinal axis, as described above. Sucha general configuration may allow for the viewing of various instrumentspassed through any of the instrument lumens 366 defined through elongatebody 360.

In this example, imaging assembly 370 may have an articulatable imagingelement 372 positioned at its distal end, which may be rotated in anynumber of directions. FIG. 31B shows a cross-sectional illustration ofthe articulatable imaging element 372 partially removed from imagingassembly 370. Imaging element 372 may generally have a rotatable housing374 containing the imager 376, e.g., CCD or CMOS chip, connected via atleast one electrical wire 380 routed through an imaging assembly lumen384 defined through assembly 370 to a proximal end of the device. Theelectrical wire 380 may be connected to a processor to allow viewing ofimages from outside the patient body. The rotatable housing 374 may berotated in any number of directions, as indicated by the arrows, byalternately tensioning any number of control wires 378 which may berouted through control wire lumens 382 defined through imaging assembly370. The distal end of imaging assembly 370 may be configured torotatingly receive and hold rotatable housing 374 in a secure mannerwhile the housing 374 is articulated.

Although imaging assembly 370 may be articulated to direct its distalend to a desired tissue region for optimal imaging, the addition of anoptional rotatable imaging element 372 may further facilitate theimaging of various tissue regions without having to reposition theentire assembly.

In yet another variation for off-axis imaging, FIGS. 32A to 32C show aninstrument where the optionally rigidizable elongate body 360 may use apull-wire 390 to control the off-axis articulation of the imagingassembly. As shown in FIG. 32A, pull-wire 390 may be routed throughskive 362 and through a pull-wire opening 392 located distal of skive362. Pull-wire 390 may be routed through pull-wire opening 392proximally through the length of elongate body 360 where the pull-wire390 may be controlled. The distal end of pull-wire 390 may be attachedto a distal end of the imaging assembly 394 at attachment point 398 andas imaging assembly or endoscope 394 is advanced through skive 362, asshown in FIG. 32B, the pull-wire 390 may be tensioned from its proximalend outside the patient body. As shown in FIG. 32C, urging or pullingpull-wire 390 may redirect or bend a distal portion 400 of the imagingassembly 394 with the imager 396 such that the imager 396 is pointed tothe region distal to the elongate body 360.

Another variation is illustrated in FIG. 33A which shows elongate body360 having a swing arm or member 410 rotatably connected via pivot 412to the elongate body 360 at a location distal to skive 362. A distal endof swing arm 410 may be attached to endoscope 394 via an attachmentmechanism 414, e.g., collar, pinned connection, adhesive, etc., suchthat when endoscope 394 is urged distally through elongate body 360 andout of skive 362, the distal end of endoscope 394 is constrained tofollow an arc by the swing arm 410 as the distal end of endoscope 394pivots about pivot 412, as shown in FIG. 33B. The length of swing arm410 may be varied depending upon the desired height and positioning ofimager 396 in its off-axis configuration.

Moreover, swing arm 410 may be configured as a simple length or it maybe configured into any number of structures provided that it is able topivot relative to elongate body 360 and position imager 396 into itsoff-axis position. Additionally, a mechanical stop may be positionedadjacent to pivot 412 to prevent over-arcing of swing arm 410;alternatively, the imaging assembly or endoscope 394 may be limited frombeing advanced distally out of skive 362 beyond a pre-determined pointto prevent over-arcing of the imager 396.

In yet another variation, a balloon 420 which is flexible in itsdeflated state may be positioned in close contact against a distalportion of the imaging assembly or endoscope 394. Balloon 420 may be influid communication through inflation lumen 422 through a length ofelongate body 360 to an inflation pump 424 located outside the patientbody, as shown in FIG. 34A. The balloon 420 may be configured such thatwhen inflated with a fluid or gas, the inflated balloon 420 conforms toa bent configuration which may be predetermined. The balloon 420 may,for instance, be inflated only along a single side such that filling theballoon 420 results in an asymmetric shape. When the endoscope 394 withballoon 420 is advanced out of skive 362, the balloon 420 may beinflated via a fluid (such as saline, water, etc.) or gas (such as air,nitrogen, carbon dioxide, etc.) such that the balloon 420 conforms toits bent configuration and also urges the wrapped endoscope 394 toconform into a bent or curved off-axis configuration, as shown in FIG.34B.

Alternatively, rather than utilizing an inflation balloon 420, ascaffold or tubular covering having a scaffold 420′ embedded thereinwhich is made from a super-elastic or shape-memory material may beconformed or wrapped around the distal portion of endoscope 394. Such ascaffold may be made from a super-elastic or shape-memory alloy such asNitinol. If a super-elastic scaffold is used, the endoscope 394 may beautomatically urged into a bent or curved configuration when advancedout of skive 362. Alternatively, a shape-memory alloy scaffold may beelectrically connected via one or more wires 422′ to a power supply424′, which may be activated to actuate the scaffold 420′ into a bent orcurved configuration.

Yet another variation is shown in FIG. 35A in which endoscope 394 may bewrapped or at least partially surrounded by a sleeve 430 having apre-formed bent or curved configuration. Sleeve 430 may be composed of asuper-elastic or shape-memory material scaffold or covering, asdescribed above, which is biased to form the bent or curvedconfiguration when unconstrained. To maintain a straightenedconfiguration when advanced through elongate body 360 and out of skive362, a straightening wire or mandrel 432, made for example fromstainless steel, Nitinol, a polymeric material, etc., may be disposedwithin sleeve 430. When sleeve 430 has been desirably positioned throughskive 362, wire or mandrel 432 may be pulled or tensioned from itsproximal end until it is withdrawn from sleeve 430, thereby allowingsleeve 430 to reconfigure itself into its relaxed configuration and toredirect imager 396 into its off-axis configuration, as shown in FIG.35B. To withdraw sleeve 430 and endoscope 394 from the patient body,endoscope 394 may be simply pulled proximally through skive 362 whilestraightening sleeve 430 and back into elongate body 360.

Another variation may utilize a sleeve 440 made from an electro-activepolymer (EAP) material such as polymer-metal composites, conductivepolymers, ferro-electric polymers, etc., as shown in FIG. 36A. EAPsleeve 440 may be wrapped completely or at least partially aboutendoscope 394 such that sleeve 440 remains flexibly compliant whenpassed through elongate body 360 and skive 362. EAP sleeve 440 may beelectrically connected via electrical connection 442 to a power supply444 located external to the patient body such that when power supply 444is activated, EAP sleeve 440 may be stimulated to reconfigure itselfinto a bent or curved off-axis configuration, as seen in FIG. 36B, suchthat imager 396 is directed distal to the elongate body 360. Shuttingpower supply 444 off may allow EAP sleeve 440 to lose its curvedconfiguration and transition back into its flexible state for withdrawalthrough skive 362 and from the patient body.

Another variation for off-axis visualization may utilize multiple, e.g.,two or more, off-axis visualization elements. Illustrated in the sideview of FIG. 37A, two or more imaging assemblies 450 which arereconfigurable between a straightened and curved configuration may beeach advanced through a corresponding lumen 366 defined through elongatebody 360. Each imaging assembly 450 may be configured such that animaging element 454, such as an optical fiber, CCD or CMOS chip, etc.,may be mounted near or at the distal end of a curved or bendable section452 such that when the curved section 452 is advanced from elongate body360, the imaging element 454 is directed into an off-axis positionrelative to the longitudinal axis defined by the elongate body 360.

In one example, two imaging assemblies 450 may be advanced through theirrespective adjacent lumens 366 and rotated within their lumens 366 toalign the respective imagers 454 to a common tissue region. In anotherexample, four imaging assemblies 450 may be advanced through respectivelumens 366, as shown in the end view of FIG. 37B, and advanced out ofelongate body 360 such that each imaging assembly 450 is radiallyconfigured in an off-axis position with respect to the longitudinal axisof elongate body 360. Moreover, each imaging assembly 450 may beuniformly or arbitrarily positioned with respect to one another in itsdeployed configuration.

In a similar variation, one or more imaging assemblies 450 may beadvanced through one or more lumens 366 while contained within a tubularretaining sleeve 456 which is retractable with respect to the imagingassembly 450, as shown in FIG. 38A. Retaining sleeve 456 may be advancedthrough lumen 366 from atraumatic distal end 368 prior to orsimultaneously with imaging assemblies 450 and retaining sleeve 456 maybe retracted relative to imaging assemblies 450 leaving the one or moreassemblies 450 to reconfigure into its curved configuration, as shown inFIG. 38B.

Another variation utilizing an inflatable balloon assembly 460 whichdefines one or more curved lumens therethrough may be utilized. As shownin FIG. 39A, an un-inflated balloon assembly 460 may lie in itscollapsed shape in a low profile against elongate body 360. When theinterior 472 of balloon 462 is inflated or expanded with a gas (such asnitrogen, carbon dioxide, air, etc.) or liquid (such as saline, water,etc.), balloon 462 which may be made from a distensible or expandablematerial may expand, as shown in FIG. 39B. In its expandedconfiguration, balloon 462 may define or more unobstructed lumens 466extending through the balloon 462 from a working lumen opening 470 inelongate body 360 and terminating in a corresponding lumen opening 464defined along a side or at the terminal end of the balloon 462, as shownin FIG. 39C.

Lumens 466 may curve radially outward within balloon 462 with respect tothe longitudinal axis of elongate body 360 and then curve radially backinwards 468 with respect to the longitudinal axis. This curvature may besuch that any tools or endoscopic instruments passed through lumen 466are directed towards the longitudinal axis of elongate body 360 and to atissue region of interest for any number of procedures to be performed.

In many endoscopic procedures, visualization of a tissue region ofinterest often requires repositioning of the imaging assembly orendoscope and re-visualizing the tissue region. Repositioning typicallyinvolves pulling or directing the endoscope away from the tissue regionand then re-visualizing the tissue region from another position or froma more proximal location. One example for endoscopically simulating therepositioning and re-visualizing of a tissue region may be seen in FIGS.40A and 40B. As illustrated in FIG. 40A, endoscope or imaging assembly480 may be advanced through elongate body 360 and out of lumen 364,where imager 484 may be articulated into a first off-axis positionrelative to a longitudinal axis of elongate body 360, as describedpreviously. In its first off-axis configuration, a target area distal toelongate body 360 may be visualized within a first field-of-view 486.

If a larger visual perspective is desired, an articulatable section 482of endoscope 480 may be further urged or articulated from its proximalend outside the patient body into a second off-axis configuration, asshown in FIG. 40B, which is more proximal than the first off-axisconfiguration. The resulting expanded field-of-view 486′ may thusprovide for a larger visual perspective of the target area beingvisualized without having to reposition a length or the entire length ofelongate body 360 relative to the visualized target area.

In another alternative, endoscope or imaging assembly 480 may bepositioned into its first off-axis configuration, as above, to provide afirst field-of-view 486, as shown in FIG. 41A. Endoscope 480 may then bewithdrawn at least partially through elongate body 360 and thenre-advanced through a skive 362 into a second off-axis configurationsuch that imager 484 is repositioned proximal of the first off-axisconfiguration to provide an expanded field-of-view 486′, as shown inFIG. 41B. Skive 362, as described herein and also in U.S. patentapplication Ser. No. 10/797,485 filed Mar. 9, 2004 (U.S. Pat. Pub. No.2004/0249367A1), which is incorporated herein by reference in itsentirety, may be defined at any number of locations along the length ofelongate body 360 proximal to the distal tip 368.

Aside from physically repositioning the endoscope or imaging assembly480, another variation may incorporate an imaging system having avariable field-of-view which may be altered by repositioning the opticswithin the imager 484. One such example of an alterable field-of-view isshown and described in U.S. Pat. Pub. No. 2005/0267335 A1 filed May 18,2005 to Okada et al., which is incorporated herein by reference in itsentirety. Such a device may be optionally incorporated into any of theimaging assemblies described herein as practicable.

In another variation for utilizing one or more skives along the lengthof elongate body 490, FIG. 42 illustrates an example in which multipleskives may be defined along the body. In this example, endoscope 394 maybe positioned into its off-axis configuration through a distallypositioned skive 362 to provide a first field-of-view. An additionalsecond skive 492 and a third skive 494 may be positioned proximallyalong the length 490 such that the endoscope 394 may be positioned inalternate proximal off-axis positions 394′, 394″ to provide alternateviews of the target area being visualized. More than three skives may beutilized along the elongate body 490, as practicable, and the skives maybe varied relative to its circumferential position, as desired. Forinstance, one or more skives may be aligned linearly along the length ofelongate body 490 such that the skives are located along the same sideof elongate body 490.

Alternatively, the one or more skives may be aligned in alternating ornon-uniform patterns. Furthermore, if the one or more skives are locatedalong different sides of the elongate body 490, multiple visualizationinstruments (or multiple other endoscopic instruments) may be passedsimultaneously through elongate body 490 to exit each skive, if sodesired.

Aside from articulating visualization assemblies into off-axisconfigurations, off-axis imaging relative to the elongate body may beprovided alternatively by utilizing various in-line angledconfigurations. One example is shown in FIG. 43A which illustrateselongate body 360 with a visualization element positioned near or at thedistal end of elongate body 360 to provide an angled field-of-view 500relative to the longitudinal axis of elongate body 360. FIG. 43B shows apartial cross-sectional view of elongate body 360, which illustrates animaging assembly 504, e.g., optical fiber bundles, having a rotatableprism assembly 502 positioned distal of the imaging assembly 504. Toalter the angle of the imaging field-of-view 500, prism 502 may berotated relative to the imaging assembly 504 via pull-wires, motors, orany other number of mechanisms. In other variations, an imaging chip,such as a CCD or CMOS chip, may be utilized to rotate in an angledconfiguration to provide the off-axis imaging.

Another example for in-line off-axis imaging is provided in FIG. 44A,which shows a partial side view of elongate body 360 having an imagingassembly 510, such as optical fibers or imaging chips, rotatablypositioned relative to elongate body 360. An off-axis imaging chip 512may be positioned near or at the distal end of imaging assembly 510.Mounted, removably or permanently, upon the distal end of elongate body360 are one or more reflectors 514 which extend distally from and whichare pivotally attached to elongate body 360. Off-axis imaging chip 512may be selectively rotated to view a tissue region by viewing imagesreflected from the one or more reflectors 514. The reflectors 514 may bemade from a number of highly reflective materials, such as polishedstainless steels or other metals, reflective glass, etc.

During endoluminal advancement through the patient body, the one or morereflectors 514 may be retracted into a low profile and then pivotedradially into an angled position to provide for imaging. Moreover, theradial expansion of the reflectors 514 may also provide for tissueretraction of any obstructing tissue structures adjacent or proximate tothe tissue region being visualized. FIG. 44B shows an end view of theradially expanded reflectors 514. To prevent pinching of tissue betweenthe expanded reflectors 514, an expandable covering 516 made from adistensible material, such as silicone, polyurethane, etc., may beoptionally provided between the reflectors 514 or around the entireimaging assembly.

In addition to providing for the off-axis visualization, whether in-lineor off-axis relative to the longitudinal axis of the elongate body,additional visualization enhancements may be optionally provided in anyof the variations described herein. One example of such a visualizationenhancement is shown in FIG. 45A, which illustrates an end view ofelongate body 360 with an imaging assembly 520 translatably positionedwithin lumen 364. Imaging assembly 520 may provide multiple adjacentimaging chips 522, e.g., CCD or CMOS chips, positioned at the distal endof assembly 520.

FIGS. 45B to 45D show a detail view of the imaging chips 522 andillustrate an example for their use. In this example, first chip 524,second chip 526, and third chip 528 may be uniformly and linearlyaligned relative to one another. To provide the visualization, firstchip 524 may be activated at a time t=t₀ to provide a firstfield-of-view 524′, as shown in FIG. 45B. The image provided in thefirst-field of view 524′ may be captured and stored via a computer (notshown). Second chip 526 may be activated subsequently at a time t=t₀+dt₁to provide a second field-of-view 526′ upon first chip 524 beingde-activated, as shown in FIG. 45C. The image provided in the secondfield-of-view 526′ may comprise an image of the region visualized whichis slightly adjacent to the image captured in the first field-of-view524′. Second field-of-view 526′ may likewise be captured and stored viathe computer. Third chip 528 may then be activated subsequently at atime t=t₀+dt₂ to provide a third field-of-view 528′ upon second chip 526being de-activated, as shown in FIG. 45D. The image provided by thethird field-of-view 528′ may likewise comprise an image of the regionwhich is slightly adjacent to the image captured in the secondfield-of-view 526′. Third field-of-view 528′ may also be captured andstored in the computer.

Once all three images have been sequentially captured, the stored imagesmay be processed via the computer or processor to result in a simulatedsingular panoramic composite image 530 of the tissue region, as shown inFIG. 45E. The sequential imaging, capturing, and displaying may becontinuously performed during a procedure to provide enhanced imaging tothe practitioner.

Another example for providing enhanced imaging in any of the variationsdescribed herein is shown in FIG. 46. In this example, imaging providedby any of the endoluminal instruments described herein may be combinedinto a fluoroscopic-endoscopic imaging system 540 where images providedby a fluoroscope 542, which is typically used to provide fluoroscopicimages via extra-corporeal imaging, may be combined with images providedby any of the endoluminal instruments 544 described herein (or even withconventional endoscopes), which provide images obtained via endoluminalintra-corporeal imaging.

A patient may be positioned upon a platform 546 for fluoroscopicimaging. The fluoroscopic images may be transmitted via electricalconnection 550 to a processor 552. The endoluminal instrument 544 may belikewise connected via electrical connection 548 to processor 552 toprovide endoluminal images. Processor 552 may be configured to processboth the fluoroscopic and endoluminal images or separate processors maybe utilized to individually process each respective images which maythen be combined via a third processor (not shown) in communication witheach separate processor.

In either case, the fluoroscopic and endoluminal images may then betransmitted and displayed via electrical connection 560 on a monitor 558and/or optionally via electrical connection 564 through goggles orglasses 562, which may be worn by the practitioner during the procedure.A switch 554 (e.g., toggle, foot switch, etc.) connected to processor552 via electrical connection 556 may be actuated by the practitioner,nurse, or technician to selectively switch the image displayed on themonitor 558 and/or goggles 562 between the fluoroscopic image and theendoluminal image. Alternatively, the fluoroscopic image and/or theendoluminal image may be displayed simultaneously on the monitor 558and/or goggles 562 in a split-screen or picture-in-picture manner toallow the practitioner to view both the fluoroscopic and endoluminalimages simultaneously without having to toggle between the two. Such asystem 540 may facilitate efficient visualization and may also reducethe amount of equipment in the operating room and/or endoscopy suiteduring a procedure.

Although various illustrative embodiments are described above, it willbe evident to one skilled in the art that a variety of combinations ofaspects of different variations, changes, and modifications are withinthe scope of the invention. It is intended in the appended claims tocover all such changes and modifications that fall within the truespirit and scope of the invention.

1. A surgical method, comprising: advancing an imager at a distal end ofan endoscope through an elongate body until the imager moves out of theelongate body through a front end opening at a distal end of theelongate body; positioning the imager at a first position to obtain afirst field of view of a surgical site; partially withdrawing theendoscope proximally until the imager is adjacent to or proximal of askive opening through a sidewall of the elongate body; re-advancing theendoscope to move the imager through the skive opening and into a secondposition outside of the elongate body, to obtain a second field of viewof the surgical site, with the second field of view different from thefirst field of view.
 2. The method of claim 1 wherein the first positionis off set to one side of the elongate body.
 3. The method of claim 1wherein a distal section of the endoscope extending out of the elongatebody has an S-shape, when the imager is in the first position.
 4. Themethod of claim 1 wherein the imager is distal of the distal end of theelongate body when the imager is in the first position.
 5. The method ofclaim 1 wherein the imager is proximal of the distal end of the elongatebody when the imager is in the second position.
 6. The method of claim 1wherein the first field of view is aligned on a first view axis thatforms an acute angle with a central axis of the elongate body.
 7. Themethod of claim 1 wherein the second field of view is aligned on asecond view axis that forms an acute angle with a central axis of theelongate body.
 8. The method of claim 1 wherein the first position iscloser to the surgical site than the second position.
 9. An endoluminalsurgical method, comprising: advancing an imager on a front end of anendoscope through an elongate body; moving the imager out of a front endof the elongate body and into a first viewing position to provide afirst field of view of a surgical site; pulling the endoscope back fromthe front end of the elongate body; steering the front end of theendoscope in an at least partially radially outward direction from acentral axis of the elongate body; advancing the front end of theendoscope through a skive opening in a sidewall of the elongate body,and steering the endoscope to move the imager to a second viewingposition to provide a second field of view of the surgical site, withthe second field of view different from the first field of view.
 10. Theendoluminal surgical method of claim 9 with first viewing position at afirst distance from the surgical site, and the second viewing positionat a second distance from the surgical site different from the firstdistance.
 11. The endoluminal surgical method of claim 9 with the firstfield of view aligned on a first view axis converging with the centralaxis of the elongate body.
 12. The endoluminal surgical method of claim9 with the second field of view aligned on a second view axis convergingwith the central axis of the elongate body.
 13. The endoluminal surgicalmethod of claim 9 with the first viewing position closer to the centralaxis of the elongate body than the second viewing position.
 14. Theendoluminal surgical method of claim 9 with the first viewing positionforward of the front end of the elongate body.
 15. The endoluminalsurgical method of claim 9 with the second viewing position behind thefront end of the elongate body.